Vaginosis, BacterialNCT03500107
Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
A study testing Blue Light Emitting Diode (LED) 401 +/- 5nm in people with Vaginosis, Bacterial, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial summary
Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- Blue Light Emitting Diode (LED) 401 +/- 5nm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Oct 2018to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women with 18 to 65 years old and with diagnosis of bacterial vaginosis
Who cannot join
- women with injury seen by Pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Cebtro de Atebçao ao Assolaho Pévico- Escola Bahiana de Medicina e Saúde Pública
Salvador, Estado de Bahia, 40290000
Patrícia Lordelo, PhD
About this study
Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.
Read the detailed description
A current treatment proposal is the use of blue LED of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.
- Conditions
- Vaginosis, Bacterial
- Being tested
- Blue Light Emitting Diode (LED) 401 +/- 5nm
- Keywords
- Blue Light Emitting Diode, Women
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue Light Emitting Diode (LED) 401 +/- 5nmDevice
Also called Questionnaire of anamnesis
The participant will be naked, in a gynecological stretcher and lithotomy position, and the apparatus of the LED will be positioned in front of the vulva and vaginal region, 5 cm away, it will be statically, externally, and supported on a tripod. The protocol will consist of only one session.
| Study group | Role | What they receive |
|---|---|---|
| Blue LED 401 +/- 5 nm | Experimental | The Blue LED 401 +/- 5 nm will be applied in the participant, in a closed room by a physiotherapist for 1 hour. The apparatus will be supported on a tripod, statically, externally, 5 cm away from the vulva abd vaginal region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol consists of only one session. This part of the study will see if there is bactericidal effect of the blue LED. Receives: Device: Blue Light Emitting Diode (LED) 401 +/- 5nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms
Measured: 15 days
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm
This exam will be done by the collect of vaginal secretion using KOH 10%
Measured: 10 minutes
Value of vaginal pH measurement in women treated by blue LED
This exam will be done by the collect of vaginal secretion using a pH measuring tape to analyse the hydrogen potential in -log 10 [pH+] in women treated by blue LED. It will be used the numeric scale of pH value
Measured: 2 minutes
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED
This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start2 Oct 2018
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Collaborators
- University of Messina, Salvatore Giovanni Vitale M.D.
- Responsible party
- Sponsor
- Investigators
- Patricia Lordelo, Study director, Centro de Atenção ao Assoalho Pélvico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500107
- Sponsor's protocol ID
- Centro CAAP
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2018
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
- ClinicalTrials.gov ID
- NCT03500107
- Acronym / sponsor ID
- Centro CAAP
- Conditions
- Vaginosis, Bacterial
- Keywords
- Blue Light Emitting Diode, Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Collaborators
- University of Messina, Salvatore Giovanni Vitale M.D.
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.
Detailed description
A current treatment proposal is the use of blue LED of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blue LED 401 +/- 5 nm | Experimental | Device: Blue Light Emitting Diode (LED) 401 +/- 5nmThe Blue LED 401 +/- 5 nm will be applied in the participant, in a closed room by a physiotherapist for 1 hour. The apparatus will be supported on a tripod, statically, externally, 5 cm away from the vulva abd vaginal region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol consists of only one session. This part of the study will see if there is bactericidal effect of the blue LED. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women with 18 to 65 years old and with diagnosis of bacterial vaginosis
Key exclusion criteria (1 listed)
- women with injury seen by Pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue Light Emitting Diode (LED) 401 +/- 5nmAlso: Questionnaire of anamnesisThe participant will be naked, in a gynecological stretcher and lithotomy position, and the apparatus of the LED will be positioned in front of the vulva and vaginal region, 5 cm away, it will be statically, externally, and supported on a tripod. The protocol will consist of only one session. | Device | Blue LED 401 +/- 5 nm |
Primary outcome
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
Time frame: 15 days
This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm
Time frame: 10 minutes
This exam will be done by the collect of vaginal secretion using KOH 10%
Value of vaginal pH measurement in women treated by blue LED
Time frame: 2 minutes
This exam will be done by the collect of vaginal secretion using a pH measuring tape to analyse the hydrogen potential in -log 10 [pH+] in women treated by blue LED. It will be used the numeric scale of pH value
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED
Time frame: 15 days
This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Lordelo study director
Centro de Atenção ao Assoalho Pélvico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue Light Emitting Diode (LED) 401 +/- 5nm in people with Vaginosis, Bacterial, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia Lordelo (+55 71 3330 1640, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm (time frame: 15 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.